Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT03811951
Eligibility Criteria:
Inclusion Criteria:
* Age between 21-40 years
* Smokers only: Begin smoking within 5 minutes of waking (verified by carbon monoxide concentrations greater than 10 ppm).
* Non-smokers only: No self-reported cigarette use in the past 1-year period.
* Non-smokers only: Carbon monoxide concentration \< 6 ppm.
* Normal vitals (blood pressure \< 120/80 mmHg; heart rate between 60 and 100 bpm, body temperature \<37 °C)
* Point-of-care (POC) blood glucose between 80 and 140 mg/dL
* Body mass index between 18.5 and 30 kg/m2
Exclusion Criteria:
* Use of non-cigarette tobacco products, e-cigarettes, or smoking cessation treatment
* Positive urine drug screen test
* Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
* Breath Alcohol Concentration \>0.00%
* Shipley IQ (Intelligence Quotient) test \<80
* Hyposmic or anosmic individuals (identifying less than 10 of 12 smells correctly)
* Abnormal physical exam of the nares
* Lifetime DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) Axis 1 disorder (except anxiety and depression)
* Current DSM-5 Axis depression or anxiety disorder
* Prescription medications
* Over-the-counter psychotropic medications
* Use of any medications administered intranasally
* Allergies to any ingredients in intranasal insulin or placebo
* Braided hair that would cause noise in EEG recording
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT03811951
Study Brief:
Protocol Section:
NCT03811951